Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
Phase 3
Completed
- Conditions
- Postmenopausal Symptoms
- Registration Number
- NCT00727129
- Lead Sponsor
- Upsher-Smith Laboratories
- Brief Summary
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 495
Inclusion Criteria
- Postmenopausal women
- Have moderate to severe hot flashes
- Normal Pap Smear
Exclusion Criteria
- Abnormal mammogram
- Abnormal clinical breast exam
- BMI >35
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Daily frequency and severity of moderate to severe vasomotor symptoms
- Secondary Outcome Measures
Name Time Method vulvar and vaginal atrophy